`PRESCRIBING INFORMATION
`
`DEXEDRINE®
`(dextroamphetamine sulfate)
`SPANSULE® sustained-release capsules and Tablets
`
`WARNING
` AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF
`AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG
`DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE
`PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR
`NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD
`BE PRESCRIBED OR DISPENSED SPARINGLY.
`MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS
`CARDIOVASCULAR ADVERSE EVENTS.
`
`DESCRIPTION
` DEXEDRINE (dextroamphetamine sulfate) is the dextro isomer of the compound d,l-amphetamine sulfate, a
`sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is
`d-alpha-methylphenethylamine, and is present in all forms of DEXEDRINE as the neutral sulfate.
`Structural formula:
`
`SPANSULE capsules: Each SPANSULE sustained-release capsule is so prepared that an initial dose is
`released promptly and the remaining medication is released gradually over a prolonged period.
` Each capsule, with brown cap and clear body, contains dextroamphetamine sulfate. The 5-mg capsule is
`imprinted 5 mg and 3512 on the brown cap and is imprinted 5 mg and SB on the clear body. The 10-mg capsule
`is imprinted 10 mg—3513—on the brown cap and is imprinted 10 mg—SB—on the clear body. The 15-mg
`capsule is imprinted 15 mg and 3514 on the brown cap and is imprinted 15 mg and SB on the clear body. A
`narrow bar appears above and below 15 mg and 3514. Product reformulation in 1996 has caused a minor
`change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl
`alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Blue No. 1 aluminum
`lake, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, propylene glycol, povidone, silicon
`dioxide, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients.
`Tablets: Each triangular, orange, scored tablet is debossed SKF and E19 and contains dextroamphetamine
`sulfate, 5 mg. Inactive ingredients consist of calcium sulfate, FD&C Yellow No. 5 (tartrazine), FD&C Yellow
`No. 6, gelatin, lactose, mineral oil, starch, stearic acid, sucrose, talc, and trace amounts of other inactive
`ingredients.
`
`KVK-TECH EXHIBIT 1054
`
`
`
`CLINICAL PHARMACOLOGY
` Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral
`actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory
`stimulant action.
` There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce
`mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the
`condition of the central nervous system.
` DEXEDRINE SPANSULE capsules are formulated to release the active drug substance in vivo in a more
`gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been
`shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given
`in divided doses.
`Pharmacokinetics: The pharmacokinetics of the tablet and sustained-release capsule were compared in 12
`healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the
`immediate-release tablet. Following administration of three 5-mg tablets, average maximal dextroamphetamine
`plasma concentrations (Cmax) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration
`of one 15-mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained
`approximately 8 hours after dosing. The average Cmax was 23.5 ng/mL. The average plasma T½ was similar for
`both the tablet and sustained-release capsule and was approximately 12 hours.
`
`In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following
`administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
`
`INDICATIONS AND USAGE
` DEXEDRINE is indicated in:
`Narcolepsy
`Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that
`typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in
`pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of
`developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity,
`emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these
`symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability,
`and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or
`may not be warranted.
`
`CONTRAINDICATIONS
` Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension,
`hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.
` Agitated states.
` Patients with a history of drug abuse.
` During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises
`may result).
`
`WARNINGS
`Serious Cardiovascular Events
`Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious
`Heart Problems: Children and Adolescents: Sudden death has been reported in association with CNS
`
`
`
`stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other
`serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death,
`stimulant products generally should not be used in children or adolescents with known serious structural cardiac
`abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may
`place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
` Adults: Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant
`drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults
`have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy,
`serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such
`abnormalities should also generally not be treated with stimulant drugs (see CONTRAINDICATIONS).
`Hypertension and Other Cardiovascular Conditions: Stimulant medications cause a modest increase in
`average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm), and individuals may have
`larger increases. While the mean changes alone would not be expected to have short-term consequences, all
`patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating
`patients whose underlying medical conditions might be compromised by increases in blood pressure or heart
`rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular
`arrhythmia (see CONTRAINDICATIONS).
`Assessing Cardiovascular Status in Patients Being Treated With Stimulant Medications:
`Children, adolescents, or adults who are being considered for treatment with stimulant medications should have
`a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and
`physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if
`findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms
`such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during
`stimulant treatment should undergo a prompt cardiac evaluation.
`Psychiatric Adverse Events
`Pre-Existing Psychosis: Administration of stimulants may exacerbate symptoms of behavior disturbance
`and thought disorder in patients with a pre-existing psychotic disorder.
`Bipolar Illness: Particular care should be taken in using stimulants to treat ADHD in patients with comorbid
`bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to
`initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately
`screened to determine if they are at risk for bipolar disorder; such screening should include a detailed
`psychiatric history, including a family history of suicide, bipolar disorder, and depression.
`Emergence of New Psychotic or Manic Symptoms: Treatment emergent psychotic or manic symptoms,
`e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of
`psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration
`should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate.
`In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1%
`(4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual
`doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
`Aggression: Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and
`has been reported in clinical trials and the postmarketing experience of some medications indicated for the
`treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or
`hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of,
`aggressive behavior or hostility.
`
`
`
`Long-Term Suppression of Growth: Careful follow-up of weight and height in children ages 7 to 10 years
`who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as
`in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months
`(to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week
`throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in
`height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of
`development. Published data are inadequate to determine whether chronic use of amphetamines may cause a
`similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore,
`growth should be monitored during treatment with stimulants, and patients who are not growing or gaining
`height or weight as expected may need to have their treatment interrupted.Seizures: There is some clinical
`evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in
`patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of
`seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
`Visual Disturbance: Difficulties with accommodation and blurring of vision have been reported with
`stimulant treatment.
`
`PRECAUTIONS
`General: The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the
`possibility of overdosage.
` The tablets contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including
`bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5
`(tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin
`hypersensitivity.
`Information for Patients: Amphetamines may impair the ability of the patient to engage in potentially
`hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned
`accordingly.
`
`Prescribers or other health professionals should inform patients, their families, and their caregivers about
`the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its
`appropriate use. A patient Medication Guide is available for DEXEDRINE. The prescriber or health
`professional should instruct patients, their families, and their caregivers to read the Medication Guide and
`should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents
`of the Medication Guide and to obtain answers to any questions they may have. The complete text of the
`Medication Guide is reprinted at the end of this document.
`Drug Interactions: Acidifying agents: Gastrointestinal acidifying agents (guanethidine, reserpine,
`glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents
`(ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the
`amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and
`efficacy of amphetamines.
` Adrenergic blockers: Adrenergic blockers are inhibited by amphetamines.
` Alkalinizing agents: Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of
`amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the
`non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents
`increase blood levels and therefore potentiate the actions of amphetamines.
` Antidepressants, tricyclic: Amphetamines may enhance the activity of tricyclic or sympathomimetic
`agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and
`
`
`
`sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be
`potentiated.
` MAO inhibitors: MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine
`metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine
`and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive
`crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal
`results.
` Antihistamines: Amphetamines may counteract the sedative effect of antihistamines.
` Antihypertensives: Amphetamines may antagonize the hypotensive effects of antihypertensives.
` Chlorpromazine: Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the
`central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning.
` Ethosuximide: Amphetamines may delay intestinal absorption of ethosuximide.
` Haloperidol: Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central
`stimulant effects of amphetamines.
` Lithium carbonate: The stimulatory effects of amphetamines may be inhibited by lithium carbonate.
` Meperidine: Amphetamines potentiate the analgesic effect of meperidine.
` Methenamine therapy: Urinary excretion of amphetamines is increased, and efficacy is reduced, by
`acidifying agents used in methenamine therapy.
` Norepinephrine: Amphetamines enhance the adrenergic effect of norepinephrine.
` Phenobarbital: Amphetamines may delay intestinal absorption of phenobarbital; co-administration of
`phenobarbital may produce a synergistic anticonvulsant action.
` Phenytoin: Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin
`may produce a synergistic anticonvulsant action.
` Propoxyphene: In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and
`fatal convulsions can occur.
` Veratrum alkaloids: Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
`Drug/Laboratory Test Interactions: Amphetamines can cause a significant elevation in plasma
`corticosteroid levels. This increase is greatest in the evening.
` Amphetamines may interfere with urinary steroid determinations.
`Carcinogenesis/Mutagenesis: Mutagenicity studies and long-term studies in animals to determine the
`carcinogenic potential of DEXEDRINE have not been performed.
`Pregnancy: Teratogenic Effects: Pregnancy Category C. DEXEDRINE has been shown to have
`embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately
`41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the
`drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no
`adequate and well-controlled studies in pregnant women, there has been 1 report of severe congenital bony
`deformity, tracheoesophageal fistula, and anal atresia (VATER association) in a baby born to a woman who
`took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. DEXEDRINE should be
`used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
` Nonteratogenic Effects: Infants born to mothers dependent on amphetamines have an increased risk of
`premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as
`demonstrated by dysphoria, including agitation, and significant lassitude.
`Nursing Mothers: Amphetamines are excreted in human milk. Mothers taking amphetamines should be
`advised to refrain from nursing.
`Pediatric Use: Long-term effects of amphetamines in pediatric patients have not been well established.
`
`
`
` Amphetamines are not recommended for use in pediatric patients under 3 years of age with Attention Deficit
`Disorder with Hyperactivity described under INDICATIONS AND USAGE.
` Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate
`symptoms of behavior disturbance and thought disorder.
` Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore,
`clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of
`stimulant medications.
` Data are inadequate to determine whether chronic administration of amphetamines may be associated with
`growth inhibition; therefore, growth should be monitored during treatment.
` Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be
`considered only in light of the complete history and evaluation of the child. The decision to prescribe
`amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s
`symptoms and their appropriateness for his or her age. Prescription should not depend solely on the presence of
`one or more of the behavioral characteristics.
` When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not
`indicated.
`
`ADVERSE REACTIONS
`Cardiovascular: Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of
`cardiomyopathy associated with chronic amphetamine use.
`Central Nervous System: Psychotic episodes at recommended doses (rare), overstimulation, restlessness,
`dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics,
`and Tourette’s syndrome.
`Gastrointestinal: Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal
`disturbances. Anorexia and weight loss may occur as undesirable effects.
`Allergic: Urticaria.
`Endocrine: Impotence, changes in libido.
`
`DRUG ABUSE AND DEPENDENCE
` Dextroamphetamine sulfate is a Schedule II controlled substance.
` Amphetamines have been extensively abused. Tolerance, extreme psychological dependence and severe
`social disability have occurred. There are reports of patients who have increased the dosage to many times that
`recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and
`mental depression; changes are also noted on the sleep EEG.
` Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia,
`irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is
`psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
`
`OVERDOSAGE
`
`Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an
`idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe
`reactions, yet doses of 400 to 500 mg are not necessarily fatal.
`In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.
`
` Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia,
`rhabdomyolysis, rapid respiration, hyperpyrexia, confusion, assaultiveness, hallucinations, panic states.
`
`
`
` Fatigue and depression usually follow the central stimulation.
` Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse.
`Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is
`usually preceded by convulsions and coma.
`
`TREATMENT
` Consult with a Certified Poison Control Center for up-to-date guidance and advice. Management of acute
`amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated
`charcoal, administration of a cathartic, and sedation. Experience with hemodialysis or peritoneal dialysis is
`inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine
`excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe
`hypertension complicates amphetamine overdosage, administration of intravenous phentolamine (Bedford
`Laboratories) has been suggested. However, a gradual drop in blood pressure will usually result when sufficient
`sedation has been achieved.
` Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat
`amphetamine intoxication.
` Since much of the SPANSULE capsule medication is coated for gradual release, therapy directed at
`reversing the effects of the ingested drug and at supporting the patient should be continued for as long as
`overdosage symptoms remain. Saline cathartics are useful for hastening the evacuation of pellets that have not
`already released medication.
`
`DOSAGE AND ADMINISTRATION
` Amphetamines should be administered at the lowest effective dosage and dosage should be individually
`adjusted. Late evening doses—particularly with the SPANSULE capsule form—should be avoided because of
`the resulting insomnia.
`Narcolepsy: Usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
` Narcolepsy seldom occurs in children under 12 years of age; however, when it does, DEXEDRINE may be
`used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments
`of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start
`with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until an optimal
`response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be
`reduced. SPANSULE capsules may be used for once-a-day dosage wherever appropriate. With tablets, give first
`dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
`Attention Deficit Disorder with Hyperactivity: Not recommended for pediatric patients under 3 years of
`age.
`
`In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised
`in increments of 2.5 mg at weekly intervals until optimal response is obtained.
`
`In pediatric patients 6 years of age and older, start with 5 mg once or twice daily; daily dosage may be
`raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be
`necessary to exceed a total of 40 mg per day.
` SPANSULE capsules may be used for once-a-day dosage wherever appropriate.
` With tablets, give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
` Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence
`of behavioral symptoms sufficient to require continued therapy.
`
`
`
`HOW SUPPLIED
`DEXEDRINE SPANSULE capsules: Each capsule, with brown cap and clear body, contains
`dextroamphetamine sulfate. The 5-mg capsule is imprinted 5 mg and 3512 on the brown cap and is imprinted
`5 mg and SB on the clear body. The 10-mg capsule is imprinted 10 mg—3513—on the brown cap and is
`imprinted 10 mg—SB—on the clear body. The 15-mg capsule is imprinted 15 mg and 3514 on the brown cap
`and is imprinted 15 mg and SB on the clear body. A narrow bar appears above and below 15 mg and 3514.
`Available: 5 mg, 10 mg, and 15 mg in bottles of 100. DEXEDRINE SPANSULE capsules are manufactured by
`Cardinal Health, Winchester, KY 40391.
` Store at controlled room temperature between 20° and 25°C (68° and 77°F) [see USP].
` Dispense in a tight, light-resistant container.
`5 mg 100s: NDC 0007-3512-20
`5 mg 90s: NDC 0007-3512-59
`10 mg 100s: NDC 0007-3513-20
`10 mg 90’s: NDC 0007-3513-59
`15 mg 100s: NDC 0007-3514-20
`15 mg 90’s NDC 0007-3514-59
`DEXEDRINE Tablets: Triangular, orange, scored, debossed SKF and E19. Available: 5 mg in bottles of 100.
`DEXEDRINE Tablets are manufactured by Abbott Laboratories, North Chicago, IL 60064.
` Store between 15° and 30°C (59° and 86°F). Dispense in a tight, light-resistant container.
`5 mg 100s: NDC 0007-3519-20
`
`
`
`
`
`Medication Guide
`DEXEDRINE®
`(dextroamphetamine sulfate) SPANSULE sustained-release capsules and Tablets CII
`Read the Medication Guide that comes with DEXEDRINE before you or your child starts taking it and each time you get a refill.
`There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s
`treatment with DEXEDRINE.
`
`
`What is the most important information I should
`know about DEXEDRINE?
`The following have been reported with use of DEXEDRINE
`and other stimulant medicines.
`1. Heart-related problems:
`• Sudden death in patients who have heart problems or
`heart defects
`• Stroke and heart attack in adults
`• Increased blood pressure and heart rate
`Tell your doctor if you or your child have any heart problems,
`heart defects, high blood pressure, or a family history of these
`problems.
`Your doctor should check you or your child carefully for heart
`problems before starting DEXEDRINE.
`Your doctor should check your or your child’s blood pressure
`and heart rate regularly during treatment with DEXEDRINE.
`Call your doctor right away if you or your child has any
`signs of heart problems such as chest pain, shortness of
`breath, or fainting while taking DEXEDRINE.
`2. Mental (Psychiatric) problems:
`All Patients
`• new or worse behavior and thought problems
`• new or worse bipolar illness
`• new or worse aggressive behavior or hostility
`Children and Teenagers
`• new psychotic symptoms (such as hearing voices,
`believing things that are not true, are suspicious) or new
`manic symptoms
`Tell your doctor about any mental problems you or your child
`have, or about a family history of suicide, bipolar illness, or
`depression.
`Call your doctor right away if you or your child have any
`new or worsening mental symptoms or problems while
`taking DEXEDRINE, especially seeing or hearing things
`that are not real, believing things that are not real, or are
`suspicious.
`What Is DEXEDRINE?
`DEXEDRINE is a central nervous system stimulant
`prescription medicine. It is used for the treatment of
`Attention-Deficit Hyperactivity Disorder (ADHD).
`
`DEXEDRINE may help increase attention and decrease
`impulsiveness and hyperactivity in patients with ADHD.
`DEXEDRINE should be used as a part of a total treatment
`program for ADHD that may include counseling or other
`therapies.
`DEXEDRINE is also used in the treatment of a sleep disorder
`called narcolepsy.
`DEXEDRINE is a federally controlled substance (CII)
`because it can be abused or lead to dependence. Keep
`DEXEDRINE in a safe place to prevent misuse and abuse.
`Selling or giving away DEXEDRINE may harm others, and
`is against the law.
`Tell your doctor if you or your child have (or have a family
`history of) ever abused or been dependent on alcohol,
`prescription medicines or street drugs.
`Who should not take DEXEDRINE?
`DEXEDRINE should not be taken if you or your child:
`• Have heart disease or hardening of the arteries
`• Have moderate to severe high blood pressure
`• Have hyperthyroidism
`• Have an eye problem called glaucoma
`• Are very anxious, tense, or agitated
`• Have a history of drug abuse
`• Are taking or have taken within the past 14 days an
`antidepression medicine called a monoamine oxidase
`inhibitor or MAOI.
`• Is sensitive to, allergic to, or had a reaction to other
`stimulant medicines
`DEXEDRINE is not recommended for use in children less than
`3 years old.
`DEXEDRINE may not be right for you or your child.
`Before starting DEXEDRINE tell your or your child’s
`doctor about all health conditions (or a family history of)
`including:
`• Heart problems, heart defects, high blood pressure
`• Mental problems including psychosis, mania, bipolar
`illness, or depression
`• Tics or Tourette’s syndrome
`• Thyroid problems
`• Seizures or have had an abnormal brain wave test (EEG)
`Tell your doctor if you or your child is pregnant, planning to
`become pregnant, or breastfeeding.
`
`
`
`
`Can DEXEDRINE be taken with other medicines?
`Tell your doctor about all of the medicines that you or your
`child take including prescription and nonprescription
`medicines, vitamins, and herbal supplements. DEXEDRINE
`and some medicines may interact with each other and cause
`serious side effects. Sometimes the doses of other medicines
`will need to be adjusted while taking DEXEDRINE.
`Your doctor will decide whether DEXEDRINE can be taken
`with other medicines.
`Especially tell your doctor if you or your child takes:
`• Anti-depression medicines including MAOIs
`• Blood pressure medicines
`• Antacids
`• Seizure medicines
`Know the medicines that you or your child takes. Keep a list of
`your medicines with you to show your doctor and pharmacist.
`Do not start any new medicine while taking DEXEDRINE
`without talking to your doctor first.
`How should DEXEDRINE be taken?
`• Take DEXEDRINE exactly as prescribed. Your doctor
`may adjust the dose until it is right for you or your child.
`• DEXEDRINE comes as a capsule or tablet.
`o DEXEDRINE SPANSULE capsules are usually taken
`once a day in the morning. DEXEDRINE SPANSULE
`is an extended release capsule. It releases medicine into
`your body throughout the day.
`o DEXEDRINE tablets are usually taken two to three
`times a day. The first dose is usually taken in the
`morning. One or two more doses may be taken during
`the day, 4 to 6 hours apart.
`• From time to time, your doctor may stop DEXEDRINE®
`treatment for a while to check ADHD symptoms.
`• Your doctor may do regular checks of the blood, heart, and
`blood pressure while taking DEXEDRINE. Children should
`have their height and weight checked often while taking
`DEXEDRINE. DEXEDRINE treatment may be stopped if a
`problem is found during these check-ups.
`• If you or your child takes too much DEXEDRINE or
`overdoses, call your doctor or poison control center
`right away, or get emergency treatment.
`What are possible side effects of DEXEDRINE?
`See “What is the most important information I should
`know about DEXEDRINE?” for information on reported
`heart and mental problems.
`Other serious side effects include:
`• Slowing of growth (height and weight) in children
`• Seizures, mainly in patients with a history of seizures
`• Eyesight changes or blurred vision
`Common side effects include:
`• Fast heart beat
`• Decreased appetite
`• Tremors
`• Headache
`• Trouble sleeping
`• Dizziness
`
`• Weight loss
`
`• Stomach upset
`• Dry mouth
`DEXEDRINE may